QA Specialist
RPK Biopharma
Sintra, Portugal
há 1 dia
source : SAPO

Detalhe da Função

Holigen is a global pharmaceutical company wishing to recruit a Quality Assurance Specialist to assist our growing team.

QA Specialist (M / F)

The Quality Assurance Specialist will be responsible for the following areas of activity :

  • Revision of Batches Documentation produced Revision of batch documentation in agreement with the market laws and product approved specifications.
  • Responsible for periodic Quality System Revision Compile the documentation required for the site quality system revision.
  • Documents Revision and Control Revision and maintenance of the site GMP documents
  • Responsible to review Controlled and Uncontrolled changes Follow up and revision of the deviations and change control systems with impact in the products manufactured.
  • Responsible to Supervise and / or Execute the product quality review Execute or supervise the periodic product revision data.
  • Recall process Supervise and / or execute the recall procedure.
  • Client Complaints Evaluate and follow-up complaints investigations.
  • Audit program Maintain and follow-up the internal audit program.
  • Training Supervision and Follow-up Supervise and follow-up the site training program.
  • Profile :

  • Science degree (Licenciatura) in : Health, Biologics or Chemical sciences
  • Experience in Quality Control would be a plus
  • Leadership and organizational skills, good written and verbal communication skills to interact with the regulatory authorities and other parties, knowledge of good manufacturing practices.
  • Required experience in Pharmaceutical industry, not less than 3 years in areas as Quality Assurance, Quality Control or Production.
  • Leadership and organizational skills, good written and verbal communication skills to interact with the different site sectors and collaborators.
  • Good documentation practices
  • Experience in leading quality investigations
  • Risk assessment skills
  • Experience in executing Audits (auditor title will be a must).
  • English Language Skills (read / wright / speak) other languages will be a must.
  • Excellent written and verbal communication skills.
  • Ability to work independently and as part of a team.
  • Excellent written and verbal communication skills.
  • High level of organisation skills and attention to detail.
  • We offer :

  • Full time position;
  • Remuneration adjusted to function and experience;
  • Work environment of excellence, focusing on quality;
  • If you can picture yourself fulfilling this position, please send us your application.

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